SAN DIEGO, April 27, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, today announced the presentation of two posters at the recent annual meeting of the European Association for the Study of the Liver (EASL), as well as the date and details of the Company's first quarter 2015 financial results conference call.
Both posters are available at http://ir.vitaltherapies.com under the "Publications and Presentations" section.
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The first poster is titled "A Randomized, Open-label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD, a Human Cell-Based Bio-Artificial Liver Support System (ELAD), in Subjects with Alcohol-Induced Liver Decompensation (AILD)." This poster describes the demographics and baseline laboratory values of subjects enrolled in VTI-208, the Company's recently enrolled pivotal, phase 3 trial. Of note, key parameters average age and MELD (Model of End-stage Liver Disease) score at baseline are within the trial's target ranges established during VTI-206, the Company's phase 2b AILD trial.
- The second poster is titled "Expression of Liver-Specific Cytochrome P450 Isoenzymes and Oxygenases in C3A Cells Prior to and After Treatment with the ELAD Liver Support System." This poster characterizes the expression levels of liver-specific cytochrome P450 isoenzymes and oxygenases in ELAD C3A cells during cartridge production and after use in clinical treatment. In particular, over 60 gene targets were detected in C3A cells, including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and CYP3A5, which are collectively responsible for metabolizing nearly 90% of all drugs as well as other cytochrome P450 enzymes involved in detoxification. Moreover, culturing C3A cells three-dimensionally within the ELAD cartridges enhanced the overall pattern of CYP expression, and comparison of C3A gene expression before and after exposure to human plasma corroborated the potential for individualized responses based on a subject's unique pathology.
Separately, the Company will release its first quarter 2015 financial results after the market closes on Tuesday, May 12, 2015. The press release will be followed by a conference call at 4:30 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review financial results and discuss other business matters.
The conference call dial-in numbers are (855) 765-5682 for domestic callers and (919) 825-3204 for international callers. The conference ID number for the call is 28877104. Participants may access the live webcast via a link on the Vital Therapies website in the Investor Relations section under "Events" at: http://ir.vitaltherapies.com/.
For those unable to dial in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 7:30 p.m. ET on May 12, 2015 to 11:59 p.m. ET on May 19, 2015. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 28877104. Additionally, an archive of the webcast will be available on the Company's website for 90 days.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment of liver failure. The Company's ELAD System is an extracorporeal bio-artificial liver therapy currently in phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies® and ELAD® are trademarks of Vital Therapies, Inc.
Vital Therapies faces risks and uncertainties including, but not limited to, the success or failure of its clinical trials and development programs; whether a single phase 3 clinical trial will be sufficient to support Food and Drug Administration (FDA) approval of a biologics license application or whether the FDA will require the Company to conduct additional clinical trials; difficulty obtaining regulatory approval in the United States or Europe, in particular for a combination product and open-label clinical trials; whether the Company begins building any significant commercial infrastructure prior to the fourth quarter of 2016; limited experience in conducting pivotal clinical trials and significant issues regarding the clinical trials, including, but not limited to, the successful opening and the continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, and unexpected adverse events or safety issues; and the sufficiency of funding. There can be no assurance that data from any of the Company's clinical trials will be sufficient to support an application for marketing in any country or that any such application will ever be approved. These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-K for the year ended December 31, 2014.